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www.fdanews.com/articles/101774-geopharma-acquires-rights-for-early-stage-diagnostic-urine-test

GeoPharma Acquires Rights for Early Stage Diagnostic Urine Test

December 4, 2007

GeoPharma has signed an agreement with the University of South Florida Research Foundation to acquire worldwide patent rights of a diagnostic technology for early stage detection of ovarian cancer using patient urine samples.

Currently, early stage diagnosis (Stage I) occurs in only 20 percent of ovarian cancer cases, GeoPharma said.

There is no approved test for early detection of ovarian cancer. The only ovarian cancer diagnostic test is the CA-125 blood test, which is approved by the FDA to monitor progression of the disease, according to the company. The CA-125 test is done serially or in combination with other physical tests, such as transvaginal sonography and pelvic examination.

Preliminary clinical studies for the diagnostic test have been conducted at the University of South Florida and further studies are in progress. GeoPharma said it plans to initiate necessary steps for FDA approval.